Evidence map›Paper›PMID 27028759›Full record

ArticleBJOG : an international journal of obstetrics and gynaecology2016

Vaginal progesterone as maintenance treatment after an episode of preterm labour (PROMISE) study: a multicentre, double-blind, randomised, placebo-controlled trial.

M Palacio, T Cobo, E Antolín, M Ramirez, F Cabrera, F Mozo de Rosales, J L Bartha, M Juan, A Martí, D Oros and 7 more

Registry-linked trialAbstract readComment
PubMed Publisher
In one paragraph

Article in BJOG : an international journal of obstetrics and gynaecology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03202836 (Vaginal Progesterone Supplementation in the Management of Preterm Labor), which is not on this map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03202836 nacompletednot on this mapstarted 2017, after this paper: background citation

Vaginal Progesterone Supplementation in the Management of Preterm Labor: A Randomized, Double Blind, Controlled Trial

TypeinterventionalSponsorChulalongkorn UniversityRan2017 to 2018Enrolled90ConditionsPreterm LaborArmsprogesterone, Tocolytics, Steroids
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Trial
  4. Trial
  5. Article
  6. Article
  7. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

17 authors.

M PalacioBCNatal, Hospital Clínic of Barcelona and Hospital Sant Joan de Déu, Fetal i+D Fetal Medicine Research Centre, IDIBAPS, University of Barcelona, Barcelona, Spain. mpalacio@clinic.cat.
T CoboBCNatal, Hospital Clínic of Barcelona and Hospital Sant Joan de Déu, Fetal i+D Fetal Medicine Research Centre, IDIBAPS, University of Barcelona, Barcelona, Spain.
E AntolínHospital General Universitario Gregorio Marañón, Madrid, Spain.
M RamirezHospital Universitario Virgen Macarena, Sevilla, Spain.
F CabreraComplejo Hospitalario Universitario lnsular Materno Infantil, Las Palmas de Gran Canaria, Spain.
F Mozo de RosalesHospital Universitario de Basurto, Bilbao, Spain.
J L BarthaHospital Puerta del Mar, Cádiz, Spain.
M JuanHospital de Son Llàtzer, Mallorca, Spain.
A MartíAlthaia Xarxa Assistencial Universitària de Manresa, Hospital de Sant Joan de Déu, Manresa, Spain.
D OrosHospital Clínico Universitario Lozano Blesa, Instituto de Investigación Sanitaria de Aragón, Red SAMID, RETICS, Zaragoza, Spain.
À RodríguezHospital de Sabadell, Corporació Sanitària Parc Taulí, Sabadell, Spain.
E ScazzocchioHospital Universitario Quirón-Dexeus, Barcelona, Spain.
J M OlivaresConsorci Sanitari de Terrassa, Terrassa, Spain.
S VareaHospital Clínic of Barcelona, Clinical Trials Unit/Clinical Pharmacology Department, Hospital Clinic Barcelona, Barcelona, Spain.
J RíosBiostatistics and Data Management Core Facility, IDIBAPS, Hospital Clinic Barcelona, Barcelona, Spain.
E GratacósBCNatal, Hospital Clínic of Barcelona and Hospital Sant Joan de Déu, Fetal i+D Fetal Medicine Research Centre, IDIBAPS, University of Barcelona, Barcelona, Spain.
PROMISE Collaborative Group

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo evaluate whether maintenance treatment with vaginal progesterone after an arrested preterm labour reduces the incidence of preterm delivery.

designMulticentre, randomised, double-blind, placebo-controlled trial.

settingTwelve tertiary care centres in Spain. POPULATION: A total of 265 women with singleton pregnancy, preterm labour successfully arrested with tocolytic treatment, and cervical length of <25 mm.

methodsRandomisation was stratified by gestational age (from 24.0 to <31.0 weeks of gestation and from 31.0 to <34.0 weeks of gestation) and centre. Patients were randomly assigned, in a 1 : 1 ratio, to either daily vaginal capsules of 200 mg progesterone or placebo until delivery or 36.6 weeks of gestation, whichever occurred first.

main outcome measuresPrimary outcome was delivery before 34.0 and 37.0 weeks of gestation. Secondary outcomes were discharge-to-delivery time, readmissions because of preterm labour, emergency service use, and neonatal morbidity and mortality.

resultsFrom June 2008 through June 2012, 1419 women were screened: 472 met the inclusion criteria and 265 were randomised. The final analysis included 258 women: 126 in the progesterone group and 132 in the placebo group. There were no significant differences between the progesterone and placebo groups in terms of delivery at <34 weeks of gestation [9/126 (7.1%) versus 10/132 (7.6%), P = 0.91] or <37 weeks of gestation [36/126 (28.6%) versus 29/132 (22.0%), P = 0.22]. There were no differences observed between groups when considering the two strata of gestational age at inclusion.

conclusionsA maintenance treatment of 200 mg of daily vaginal progesterone capsules in women discharged home after an episode of arrested preterm labour did not significantly reduce the rate of preterm delivery. TWEETABLE ABSTRACT: Maintenance progesterone in 258 women after arrested PTL showed no benefit.

Indexed as

Double-Blind MethodFemaleHumansInfant, NewbornObstetric Labor, PrematurePremature BirthProgesteroneVaginaProgesteroneMaintenance treatmentpreterm labourprogesterone

Identifiers

PMID27028759

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